NCT02856308

Brief Summary

This is a prospective, single-arm, multi-center, international, open-label, non-randomized, clinical study. The aim of the study is to assess the safety and efficacy of the use of the Hairstetics hair implant device in subjects affected with hair loss.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
4 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

4 years

First QC Date

July 7, 2016

Last Update Submit

August 8, 2017

Conditions

Alopecia

Outcome Measures

Primary Outcomes (1)

  • Acceptable number, duration and severity of expected adverse device/procedure effects

    3 months following implantation

Study Arms (1)

Hairstetics hair implant device

EXPERIMENTAL

Subjects will undergo the Hairstetics prosthetic hair implantation starting with a test of up to 100 fibers and up to 2 additional implantation sessions with up to 1500 fibers overall per subject. The implantation will be carried out according to the device IFU.

Device: Hairstetics hair implant device

Interventions

Hairstetics hair implant deviceDEVICE
Hairstetics hair implant device

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is ≥ 19 years old.
  • Subject has hair loss and has chosen to undergo synthetic hair implantation.
  • Subject has mental capacity to understand study guidelines and requirements (to maintain scalp hygiene, use of shampoo, delicate combing, etc.).
  • Subject has been evaluated by the investigator to have a scalp condition in the planned area of implantation that is acceptable for entering the study and currently is NOT suffering from skin problems at planned implantation site or elsewhere that might affect the procedure and/or success as clinically evaluated by the investigator.
  • Subject has Good general health.
  • Woman of child bearing potential must have a negative pregnancy test.
  • Subject willing to sign a written informed consent form (ICF) and the post implantation maintenance protocol.

You may not qualify if:

  • Previous synthetic hair implantation or hair transplantation in the past 6 months.
  • Currently suffering from skin problems at planned implantation site or elsewhere that might affect the procedure and/or success as clinically evaluated by the investigator.
  • Currently receiving or have within the past 3 months received radiation- and/or chemotherapy.
  • Currently using steroid product with Immunosuppressive treatment.
  • Impaired coagulation.
  • Serious illness that may affect subject compliance to protocol.
  • Subject is using illegal drugs.
  • Participating in other clinical study.
  • Known allergy or hypersensitivity to Nitinol or Nickel or Titanium
  • For woman: Pregnancy or breast feeding.
  • Known allergy or intolerance for the prescribed antibiotics and in such a case, a different antibiotics for which the subject is not allergic or intolerance to, will be prescribed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Cabinet du Dr G. Beilin

Paris, France

RECRUITING

Cabinet médical du Dr Jack Smadja

Paris, France

RECRUITING

Georges Mandel Office Surgery Clinic

Paris, France

RECRUITING

Paras hospital

Gūrgaon, 122002, India

RECRUITING

Fortis Hospital

New Delhi, 110088, India

RECRUITING

Egoclinic

Bucharest, Romania

RECRUITING

Metropolitan hospital

Bucharest, Romania

RECRUITING

Revere clinic

London, W1G7JA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Igal Ruvinsky, PhD

CONTACT

+972-72-2501630igal.r@hairstetics.com

Boaz Shenhav

CONTACT

+972-72-2501630boaz.s@hairstetics.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2016

First Posted

August 4, 2016

Study Start

March 1, 2014

Primary Completion

March 1, 2018

Study Completion

September 1, 2018

Last Updated

August 9, 2017

Record last verified: 2017-08

Locations

GB(1)FR(3)RO(2)IN(2)